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Description of Treatment Patterns and Population Characteristics of Pre-dialysis CKD Patients in the Czech Republic

Description of Treatment Patterns and Population Characteristics of Pre-dialysis CKD Patients in the Czech Republic

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05380843
Enrollment
1200
Registered
2022-05-19
Start date
2022-05-16
Completion date
2023-06-30
Last updated
2023-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Keywords

epidemiological survey, renal failure, decreased renal function, dialysis, low protein diet, treatment alternatives, Clinical Frailty Scale, Mini Nutritional Assessment (MNA), Bansal Score

Brief summary

The decision making in the Czech nephrology offices depends on the local common practice which is likely to be heterogenous. In other words, the same patient would be indicated to different therapy and regimen at different sites. To date, the practices and treatment paths have not been described. The aim of the present epidemiological research is to characterize the population of CKD patients at the point of treatment choice and to outline the motivation of nephrologist to initiate particular therapy.

Detailed description

This is epidemiological (observational) cross-sectional survey. Data for the research will be obtained from clinical records and patient´s questionnaires and transcribed into electronic case report forms (eCRF) by physician anonymized using subject ID. This observational research will not impose any additional procedures, assessments, or changes in addition to the routine management of subjects. The research does not aim to follow treatment with a single medicinal product. The management of patients will be described in general terms. Names of active substances will be collected rather than the names of individual products.

Interventions

None listed

Sponsors

Value Outcomes Ltd.
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Adult patient of 18 years and older * Signed consent with processing of personal data as per the GDPR and the applicable national legal requirements * Chronic kidney disease (CKD) category 4 to 5 characterized by GFR \< 30 ml/min/1.73m2 for at least 3 months

Exclusion criteria

* Patients on chronic dialysis * Patient waiting for kidney transplant * Patient requiring indication of dialysis (e.g., life-threatening changes in fluid, electrolyte, and acid-base balance, serositis, pruritus, inability to control blood pressure, lethargy or other changes in mental status, symptoms of uraemia, GFR \< 10 ml/min/1.73 m2) * Patient with altered mental state unable to fill patient questionnaires

Design outcomes

Primary

MeasureTime frameDescription
Sociodemographic parametersthrough study completion, an average of 3 monthsage, gender, ethnicity, health insurance company, education, marital status and cohabitation, employment status/disability, type of employment

Secondary

MeasureTime frameDescription
Laboratory parametersthrough study completion, an average of 3 monthsalbumin (in g/l)
Prognosisthrough study completion, an average of 3 monthsBansal score (min. 0, max. 17, higher score means the worse prognosis)
Functional status/frailty/performancethrough study completion, an average of 3 monthsClinical frailty scale (min. 1, max. 9, higher score means higher frailty)
Medical history and anthropometrythrough study completion, an average of 3 monthsBMI (in kg/m\^2)
Decision of future managementthrough study completion, an average of 3 monthsChoice of future management (conservative management, conservative management with ketoanalogues, dialysis)
Physician attitude to the choice of therapy + reasonsthrough study completion, an average of 3 monthsPhysician motivation/reasons for treatment choices
Patient attitude to the choice of therapy + reasonsthrough study completion, an average of 3 monthsPatient motivation/reasons for treatment choices
Nutritionthrough study completion, an average of 3 monthsnutritional status (Full MNA assessment), ketoanalogues, salt intake, protein intake, nutritional education (flyers, consultations etc.), attitude/future adherence to prescribed dietary restrictions

Countries

Czechia

Contacts

Primary ContactJan Tužil, Mgr.
jan.tuzil@valueoutcomes.cz727824059

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026